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临床试验/CTRI/2024/06/069629
CTRI/2024/06/069629招募中Phase 3 4

Randomised control trial comparing nasogastric tube feeding and feeding jejunostomy in head and neck cancer patients undergoing radiotherapy

Yenepoya University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年7月6日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
入组人数
33
试验地点
1
主要终点
Compare the mean weight loss and percentage of patients with head and neck cancer completing the course of curative radiotherapy who have been randomised to receive

研究概览

简要总结

This is a randomised control study where patients with head & neck cancer undergoing curative radiotherapy will be randomised to get a nasogastric tube or a feeding jejunostomy for nutritional support prior to the start of radiotherapy. The two groups will be compared to study the effect of type of feeding procedure on completion of radiotherapy and weight loss.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with head & neck cancer undergoing curative radiotherapy who require insertion of a feeding tube.

排除标准

  • Patients with head & neck cancer undergoing curative radiotherapy who aren’t willing for insertion of a feeding tube
  • Patients with head & neck cancer undergoing radiotherapy on outpatient basis
  • Patients who are critically ill.

结局指标

主要结局

Compare the mean weight loss and percentage of patients with head and neck cancer completing the course of curative radiotherapy who have been randomised to receive

时间窗: Baseline Weight checked prior to start of tube feeding and Weight checked at completion or discontinuation of radiotherapy at around less than or equal to six weeks

nasogastric tube or feeding jejunostomy

时间窗: Baseline Weight checked prior to start of tube feeding and Weight checked at completion or discontinuation of radiotherapy at around less than or equal to six weeks

次要结局

  • N/A(N/A)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mekha Ann Andrews

Yenepoya University

研究点 (1)

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